Label: BRIMONIDINE TARTRATE solution/ drops

  • NDC Code(s): 0363-9960-15, 0363-9960-25, 0363-9960-75
  • Packager: Walgreens Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 14, 2023

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  • ACTIVE INGREDIENT

    Brimonidine tartrate (0.025%)

  • PURPOSE

    Redness reliever

  • USE

    • relieves redness of the eye due to minor eye irritations

  • WARNINGS

    For external use only

  • DO NOT USE

    • if solution changes color or becomes cloudy

  • STOP USE AND ASK DOCTOR IF

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 3 days
  • IF PREGNANT OR BREASTFEEDING

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DIRECTIONS

    • adults and children 5 years of age and over:
    • instill 1 drop in the affected eye(s) every 6-8 hours
    • do not use more than 4 times daily
    • remove contact lenses before use
    • wait at least 10 minutes before re-inserting contact lenses after use
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
    • children under 5 years of age: consult a doctor
  • OTHER INFORMATION

    • store at 15° to 25°C (59° to 77°F)

  • INACTIVE INGREDIENTS

    benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

  • QUESTIONS OR COMMENTS?

    call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

  • PRINCIPAL DISPLAY PANEL

    BRIMONIDINE TARTRATE 
    OPHTHALMIC SOLUTION 0.025% 
    REDNESS RELIEVER EYE DROPS 


    •Works in 1 minute 
    •Lasts up to 8 hours 


    Sterile 
    0.08 FL OZ (2.5 mL)

    Placeholder



    BRIMONIDINE TARTRATE 
    OPHTHALMIC SOLUTION 0.025% 
    REDNESS RELIEVER EYE DROPS 


    •Works in 1 minute 
    •Lasts up to 8 hours 


    Sterile 
    0.25 FL OZ (7.5 mL) 

    Placeholder

      

  • INGREDIENTS AND APPEARANCE
    BRIMONIDINE TARTRATE 
    brimonidine tartrate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9960
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE) BRIMONIDINE TARTRATE0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9960-251 in 1 CARTON05/16/2024
    12.5 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:0363-9960-751 in 1 CARTON05/16/2024
    27.5 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:0363-9960-152 in 1 CARTON05/16/2024
    37.5 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21636102/28/2024
    Labeler - Walgreens Company (008965063)
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